Anxiety DisordersNCT04868201
A Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Anxiety Disorder in Children
A study testing 0-anxiety in people with Anxiety Disorders, run by Universidade Federal do Rio de Janeiro.
Trial summary
To examine the efficacy of a fully self-guided app-based virtual reality cognitive behavior therapy (VR CBT) using low-cost (cardboard) virtual reality goggles compared with a wait-list control group and to determine its user friendliness. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- 0-anxiety
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- individuals must be between 8-12 years old;
- subjects must score above 25 on the SCARED questionnaire;
- subjects must have access to a smart phone and internet;
- individuals must be willing to participate in the research study and providing informed consent.
Who cannot join
- children that present with symptoms of severe depression or suicidality as measured with KSADS-PL26;
- children that have insufficient knowledge of the Portuguese language;
- subjects that are under any current treatment for anxiety disorder or using psychotropic medication.
About this study
To examine the efficacy of a fully self-guided app-based virtual reality cognitive behavior therapy (VR CBT) using low-cost (cardboard) virtual reality goggles compared with a wait-list control group and to determine its user friendliness. We hypothesize that children with GAD enrolled in the self-guided app will present lower scores of anxiety.
Read the detailed description
A randomized controlled design will be carried out, in which the effectiveness and user- friendliness of an online app-based VR self-help treatment '0-anxiety' will be evaluated. Our primary objective is to determine the clinical effects (a reduction in anxiety symptoms at post-test [between the experimental condition and controls] of 0-anxiety, and whether effects are sustainable at follow-up [a reduction in anxiety symptoms between baseline and follow-up for those in the experimental condition]). Our secondary objective is to determine the user-friendliness of 0-anxiety. In this study, 230 children from the Brazilian population will be randomized over 2 conditions: the experimental condition (0-anxiety) and a waitlist condition. The duration of the intervention will be 3 weeks. Measures will be taken at baseline, directly after the intervention (3 weeks) and at 3 months (follow-up). All measures will be completed online. Therefore, the child will participate in the study in his/her natural environment. Subjects in the wait-list condition will receive the intervention after completion of the post-test. Randomization (block-randomization) will be performed by an independent researcher.
- Conditions
- Anxiety Disorders
- Being tested
- 0-anxiety
- Keywords
- anxiety, virtual reality, app, self-guided, Cognitive behavior therapy
- Medical subject headings
- Anxiety Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0-anxietyDevice
0-anxiety is a self-guided app-based utilizing virtual reality establish in cognitive behavior therapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| 0-anxiety | Experimental | 0-anxiety is based on the principles of VRT and CBT, which currently is the most researched and used treatment for anxiety disorders. The 0-anxiety intervention is an app-based intervention consisting of six modules that can be followed according to a user's own timing and without the intervention of a therapist. Receives: Device: 0-anxiety |
| wait-list condition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety levels
Screen for Child Anxiety Related Disorders (SCARED). A score above 25 indicates a significant level of anxiety. Higher scores mean worse anxiety levels.
Measured: baseline and and 3 months after the completion of the intervention
Secondary outcomes (2)
Fear Survey Schedule for Children-Revised (FSSC-R)
The FSSC-R is a widely used self-report measure of children and adolescents' fears. The instrument, a revision of Scherer and Nakamura's (1968) original Fear Survey Schedule for Children, contains 80 items that are each rated on a three-point scale (none, some, a lot). A total fearfulness score can be obtained, as can five subscale scores based on a factor analysis of the items. In addition, the number of intense fears can be indicated (i.e., the number of fears endorsed 'a lot'), as can the most prevalent fears for a given child/adolescent or group of children and adolescents (i.e., boys, preadolescents, school phobic youngsters, etc.). Higher scores mean worse fear levels.
Measured: baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention
Spence Children's Anxiety Scale - Parent and Children version
The scale is completed by a parent of an anxious child between the ages of 6 to 18. It provides an overall measure of anxiety together with scores on six sub-scales each tapping a specific aspect of child anxiety. - Panic attack and agoraphobia - Separation anxiety - Physical injury fears - Social phobia - Obsessive compulsive - Generalized anxiety disorder / overanxious disorder. This yields a maximum possible score of 114. Higher scores mean worse anxiety levels.
Measured: baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laiana A. Quagliato, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868201
- Sponsor's protocol ID
- 74646917.1.0000.5263
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Anxiety Disorder in Children
- ClinicalTrials.gov ID
- NCT04868201
- Acronym / sponsor ID
- 74646917.1.0000.5263
- Conditions
- Anxiety Disorders
- Keywords
- anxiety, virtual reality, app, self-guided, Cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the efficacy of a fully self-guided app-based virtual reality cognitive behavior therapy (VR CBT) using low-cost (cardboard) virtual reality goggles compared with a wait-list control group and to determine its user friendliness. We hypothesize that children with GAD enrolled in the self-guided app will present lower scores of anxiety.
Detailed description
A randomized controlled design will be carried out, in which the effectiveness and user- friendliness of an online app-based VR self-help treatment '0-anxiety' will be evaluated. Our primary objective is to determine the clinical effects (a reduction in anxiety symptoms at post-test [between the experimental condition and controls] of 0-anxiety, and whether effects are sustainable at follow-up [a reduction in anxiety symptoms between baseline and follow-up for those in the experimental condition]). Our secondary objective is to determine the user-friendliness of 0-anxiety. In this study, 230 children from the Brazilian population will be randomized over 2 conditions: the experimental condition (0-anxiety) and a waitlist condition. The duration of the intervention will be 3 weeks. Measures will be taken at baseline, directly after the intervention (3 weeks) and at 3 months (follow-up). All measures will be completed online. Therefore, the child will participate in the study in his/her natural environment. Subjects in the wait-list condition will receive the intervention after completion of the post-test. Randomization (block-randomization) will be performed by an independent researcher.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0-anxiety | Experimental | Device: 0-anxiety0-anxiety is based on the principles of VRT and CBT, which currently is the most researched and used treatment for anxiety disorders. The 0-anxiety intervention is an app-based intervention consisting of six modules that can be followed according to a user's own timing and without the intervention of a therapist. |
| wait-list condition | No intervention | – |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- individuals must be between 8-12 years old;
- subjects must score above 25 on the SCARED questionnaire;
- subjects must have access to a smart phone and internet;
- individuals must be willing to participate in the research study and providing informed consent.
Key exclusion criteria (3 listed)
- children that present with symptoms of severe depression or suicidality as measured with KSADS-PL26;
- children that have insufficient knowledge of the Portuguese language;
- subjects that are under any current treatment for anxiety disorder or using psychotropic medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0-anxiety0-anxiety is a self-guided app-based utilizing virtual reality establish in cognitive behavior therapy treatment. | Device | 0-anxiety |
Primary outcome
Anxiety levels
Time frame: baseline and and 3 months after the completion of the intervention
Screen for Child Anxiety Related Disorders (SCARED). A score above 25 indicates a significant level of anxiety. Higher scores mean worse anxiety levels.
2 secondary outcomes
Fear Survey Schedule for Children-Revised (FSSC-R)
Time frame: baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention
Spence Children's Anxiety Scale - Parent and Children version
Time frame: baseline, 3 weeks after the intervention, and 3 months after the completion of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 0-anxiety in people with Anxiety Disorders, run by Universidade Federal do Rio de Janeiro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety levels (time frame: baseline and and 3 months after the completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.